UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059379 |
|---|---|
| Receipt number | R000067912 |
| Scientific Title | Evaluation of the Usefulness of Continuous Positive Airway Pressure (CPAP) during EBUS-GS Guided Transbronchial Biopsy for Small Peripheral Pulmonary Lesions |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/12 16:09:15 |
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Basic information
Public title
Evaluation of the Usefulness of Continuous Positive Airway Pressure (CPAP) during EBUS-GS Guided Transbronchial Biopsy for Pulmonary Lesions
Acronym
Usefulness of CPAP during Transbronchial Lung Biopsy
Scientific Title
Evaluation of the Usefulness of Continuous Positive Airway Pressure (CPAP) during EBUS-GS Guided Transbronchial Biopsy for Small Peripheral Pulmonary Lesions
Scientific Title:Acronym
CPAP in EBUS-GS Guided Biopsy for Small Peripheral Pulmonary Lesions
Region
| Japan |
Condition
Condition
Peripheral lung lesion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnostic yield of bronchoscopic biopsy under CPAP for peripheral pulmonary lesions.
Basic objectives2
Others
Basic objectives -Others
Diagnostic yield of bronchoscopic biopsy under CPAP for peripheral pulmonary lesions with a negative CT bronchus sign.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Diagnostic yield of bronchoscopic biopsy under CPAP for peripheral pulmonary lesions
Key secondary outcomes
Diagnostic yield of bronchoscopic biopsy under CPAP for peripheral pulmonary lesions with a negative CT bronchus sign.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
We are planning to use continuous positive airway pressure (CPAP) to keep the airways open during bronchoscopy, in order to improve lesion access and increase the diagnostic yield for small peripheral lung lesions.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who visit Fujita Health University Hospital and require a pathological diagnosis by bronchoscopy for a pulmonary nodule or opacity that meets all of the following criteria:
Patients who have received a full explanation about this study, fully understood the contents, and have provided written informed consent of their own free will.
Patients aged 20 years or older and younger than 90 years at the time of consent.
Patients with a target lesion less than or equal to 2 cm in the longest diameter on chest CT.
Patients who have undergone thin-slice chest CT (slice thickness less than 2 mm) prior to bronchoscopy.
Key exclusion criteria
Patients with an evident pneumothorax prior to the procedure.
Patients with respiratory failure (PaO2 less than 60 torr).
Patients whose systolic blood pressure is below 80 mmHg immediately before the start of bronchoscopy.
Any other patients judged to be inappropriate for inclusion by the principal investigator or sub-investigators.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Imaizumi |
Organization
Fujita Health University
Division name
Department of Respiratory Medicine
Zip code
4701192
Address
95 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
09065740609
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Imaizumi |
Organization
Fujita Health University
Division name
Department of Respiratory Medicine
Zip code
4560036
Address
95 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
09065740609
Homepage URL
jeanluc@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Kauzyosshi Imaizumi
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine, Fujita Health University
Address
95 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562939241
jeanluc@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
愛知
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067912
